Browse Drug Recalls
972 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 972 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Drug Safety Recalls
Browse 972 FDA drug recalls in TX.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 12, 2021 | TRI-TEST 200 (CY50%-EN37.5%-PR12.5%) INJ #1 200MG/ML INJECTABLE, Rx only, Tal... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | ALPROSTADIL 40MCG/ML INJ 40MCG/ML INJECTABLE, Rx only, Talon Compounding Pha... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | B COMPLEX INJ CMP-NO B12, NO LIDOCAINE INJECTABLE, Rx only, Talon Compoundin... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Sep 23, 2021 | Hydroquinone USP, 4% Skin Bleaching Cream, Rx only, Net Wt 1 oz (28.35g), Man... | Finished product specification did not meet USP specifications. | Class II | Monarch PCM, LLC |
| Sep 1, 2021 | Sodium Sulfacetamide, 10%, Wash, packaged in bottles: a) 6 fl oz (177 mL) NDC... | Subpotency: one product for active ingredient assay and another one for preservative assay | Class III | Monarch PCM, LLC |
| Sep 1, 2021 | Hydroquinone, USP, 4% Skin Bleaching Cream, packaged in 1 oz (28.35g) tube, R... | Subpotency: one product for active ingredient assay and another one for preservative assay | Class III | Monarch PCM, LLC |
| Aug 18, 2021 | Spironolactone Ophthalmic Solution 0.005 mg/mL, 15 mL bottles, Rx only, Green... | Lack of Assurance of Sterility | Class II | Prescription Labs Inc dba Greenpark |
| Aug 11, 2021 | Hydro Pinapple Burn Max Health Thach Dua, packaged in a box containing 20g x ... | Marketed without an approved NDA/ ANDA - presence of undeclared sibutramine | Class I | Ebay Seller - John Nguyen |
| Jul 9, 2021 | Compounded Lyophilized AOD-9604, 3 mg For subcutaneous or intramuscular injec... | Lack of Assurance of Sterility | Class II | Innoveix Pharmaceuticals Inc |
| Jul 9, 2021 | Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramus... | Lack of Assurance of Sterility | Class II | Innoveix Pharmaceuticals Inc |
| May 18, 2021 | PremierZEN Gold 7000 capsule, 1-count blister card, packaged in 12 cards per ... | Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil. | Class I | Miracle 8989 |
| May 18, 2021 | maXXzen Platinum 12000 capsule, 1-count blister card (UPC 7 18122 04072 8), D... | Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil. | Class I | Miracle 8989 |
| May 18, 2021 | PremierZEN Platinum 8000 capsule, 1-count blister card (UPC 7 28175 42185 6),... | Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil. | Class I | Miracle 8989 |
| Apr 20, 2021 | BD ChloraPrep Hi-Lite Orange 26 mL Applicator (2% w/v chlorhexidine gluconate... | Defective Delivery System: An increase in complaints identified endcap being loose or falling off... | Class I | CareFusion 213, LLC |
| Mar 19, 2021 | ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropy... | CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Rel... | Class II | CareFusion 213, LLC |
| Mar 19, 2021 | ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... | Microbial Contamination of Non-Sterile Product:.Product is being recalled because at labeled stor... | Class I | CareFusion 213, LLC |
| Mar 19, 2021 | BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... | Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions ... | Class II | CareFusion 213, LLC |
| Mar 19, 2021 | BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v... | Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions ... | Class II | CareFusion 213, LLC |
| Mar 19, 2021 | BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v... | Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relativ... | Class I | CareFusion 213, LLC |
| Mar 19, 2021 | ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... | CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Rel... | Class II | CareFusion 213, LLC |
| Mar 19, 2021 | BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... | Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relativ... | Class I | CareFusion 213, LLC |
| Mar 19, 2021 | ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropy... | Microbial Contamination of Non-Sterile Product.Product is being recalled because at labeled stora... | Class I | CareFusion 213, LLC |
| Nov 17, 2020 | REGENECARE HA (Lidocaine HCL 2%) Topical Anesthetic Hydrogel, Net Wt. 3 oz. (... | Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated wit... | Class I | MPM Medical LLC |
| Oct 5, 2020 | FENTANYL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 575MCG-18MG-6000MCG/ML, 21 mL... | Non-Sterility | Class I | Med Shop Total Care Inc. |
| Oct 5, 2020 | HYDROMORPHONE HCL-BUPIVACAINE HCL-SUFENTANIL PF 25MG-9MG-110MCG/ML INJECTABLE... | Non-Sterility | Class I | Med Shop Total Care Inc. |
| Oct 5, 2020 | SUFENTANIL-BUPIVACAINE-BACLOFEN PF 25MCG-12.5MG-750MCG/ML INJECTABLE 41 mL sy... | Non-Sterility | Class I | Med Shop Total Care Inc. |
| Oct 5, 2020 | MORPHINE-BUPIVACAINE-KETAMINE PF INJECTABLE 21 mL syringe in two strengths: a... | Non-Sterility | Class I | Med Shop Total Care Inc. |
| Oct 5, 2020 | MORPHINE-BUPIVACAINE-FENTANYL PF 30MG-15MG-2000MCG/ML INJECTABLE 21 mL syring... | Non-Sterility | Class I | Med Shop Total Care Inc. |
| Oct 5, 2020 | HYDROMORPHONE HCL-BUPIVACAINE HCL PF INJECTABLE 21 and 22 mL syringes in vari... | Non-Sterility | Class I | Med Shop Total Care Inc. |
| Oct 5, 2020 | BUPIVACAINE HCL-LIORESAL PF INJECTABLE 7.5MG-1625MCG/ML, 41 mL syringe, Rx on... | Non-Sterility | Class I | Med Shop Total Care Inc. |
| Oct 5, 2020 | MORPHINE-BUPIVACAINE PF INJECTABLE 21 mL, 22 mL, 23 mL, 41 mL and 43 mL syrin... | Non-Sterility | Class I | Med Shop Total Care Inc. |
| Oct 5, 2020 | FENTANYL-BUPIVACAINE HCL PF INJECTABLE 3000MCG-12MG/ML, 21 mL syringe, Rx onl... | Non-Sterility | Class I | Med Shop Total Care Inc. |
| Oct 5, 2020 | HYDROMORPHONE HCL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 21 mL syringes in v... | Non-Sterility | Class I | Med Shop Total Care Inc. |
| Oct 5, 2020 | MORPHINE-HYDROMORPHONE-BUPIVACAINE PF 13MG-19MG-2MG/ML INJECTABLE 21 mL syrin... | Non-Sterility | Class I | Med Shop Total Care Inc. |
| Oct 5, 2020 | HYDROMORPHONE HCL-BUPIVACAINE HCL-FENTANYL PF INJECTABLE 21 mL syringe in var... | Non-Sterility | Class I | Med Shop Total Care Inc. |
| Oct 5, 2020 | HYDROMORPHONE HCL-BUPIVACAINE HCL-CLONIDINE HCL PF INJECTABLE 21 mL syringes ... | Non-Sterility | Class I | Med Shop Total Care Inc. |
| Oct 5, 2020 | BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 40MG-4000MCG/ML, 21 mL syringe, Rx onl... | Non-Sterility | Class I | Med Shop Total Care Inc. |
| Sep 24, 2020 | SYP Health Hand Sanitizer Alcohol Gel (ethyl alcohol) 70%, Net Wt. 16.91 FL O... | CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled... | Class II | AA PRODUCTS INC |
| Sep 9, 2020 | M Hand Sanitizer Ethyl Alcohol Antiseptic 80%v/v, Topical Solution 128 oz/3,7... | Chemical Contamination and Subpotent Drug: FDA analysis found product to contain methanol and bel... | Class I | MEDEK LLC |
| Sep 1, 2020 | Red-E Tablet, Proprietary Blend 3000 mg**, packaged in 1-count plastic bag st... | Marketed Without An Approved NDA/ANDA: product found to be tainted with sildenafil, an FDA approv... | Class I | The Protein Shoppe |
| Aug 7, 2020 | UltraCruz Hand Sanitizing Gel Antimicrobial (70% Isopropyl Alcohol), packaged... | Subpotent drug | Class II | Santa Cruz Biotechnology, Inc |
| Aug 4, 2020 | Ear Pain MD Pain Relief Drops For Kids (lidocaine HCl Monohydrate 4%) 0.5 FL ... | cGMP Deviations. | Class II | Eosera, Inc. |
| Aug 4, 2020 | Ear Pain MD Pain Relief Drops with 4% Lidocaine (lidocaine HCl Monohydrate 4%... | cGMP Deviations. | Class II | Eosera, Inc. |
| Aug 4, 2020 | Day & Night Pack Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%), 0.5 FL OZ (1... | cGMP Deviations. | Class II | Eosera, Inc. |
| Aug 4, 2020 | Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%) 0.5 FL OZ (15 mL) bottles, Eos... | cGMP Deviations. | Class II | Eosera, Inc. |
| Jul 11, 2020 | blumen ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT, (ethyl alcohol 70% v/v) P... | Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below th... | Class I | 4e Brands North America, Llc |
| Jul 11, 2020 | blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% Natural Boost ... | CGMP Deviations: recalled because it was manufactured in the same facility as the product found t... | Class II | 4e Brands North America, Llc |
| Jul 11, 2020 | blumen Aloe ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT (70% ethyl alcohol v/... | CGMP Deviations: recalled because it was manufactured in the same facility as the product found t... | Class II | 4e Brands North America, Llc |
| Jul 11, 2020 | blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% natural boost ... | Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below th... | Class I | 4e Brands North America, Llc |
| Jul 11, 2020 | blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v... | Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below th... | Class I | 4e Brands North America, Llc |
Frequently Asked Questions
When a drug safety issue is identified, through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks, the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.
The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.
Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.